Idorsia submits European marketing authorisation application for aprocitentan for the treatment of patien
- The application includes data from the Phase 3 registration study of patients with resistant hypertension, where aprocitentan demonstrated a sustained blood pressure reduction over 48 weeks and was well-tolerated
Allschwil, Switzerland January 31, 2023
Idorsia Ltd IDIA today announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for aprocitentan, Idorsia's investigational, novel dual endothelin receptor antagonist, for the treatment of patients with resistant hypertension.
The MAA includes data from a comprehensive clinical and non-clinical development program. In the Phase 3 registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to combination background antihypertensive therapy in patients with resistant hypertension. In PRECISION, aprocitentan was generally well tolerated with no major safety concerns. The most frequent adverse event with aprocitentan was mild-to-moderate edema/fluid retention.
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